Guidance to develop individual dose recommendations for patients on chronic hemodialysis.

Détails

ID Serval
serval:BIB_6988A7B73890
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
Guidance to develop individual dose recommendations for patients on chronic hemodialysis.
Périodique
Expert review of clinical pharmacology
Auteur(s)
Gotta V., Dao K., Rodieux F., Buclin T., Livio F., Pfister M.
ISSN
1751-2441 (Electronic)
ISSN-L
1751-2433
Statut éditorial
Publié
Date de publication
07/2017
Peer-reviewed
Oui
Volume
10
Numéro
7
Pages
737-752
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
In addition to tailored clinical trials in patients on chronic hemodialysis (HD) during drug development, clinician-initiated post-marketing studies and case reports on individual pharmacokinetic (PK) assessments provide an important source of information about drug dialysability and individualized dose recommendations in this vulnerable population. Areas covered: First, factors that may alter drug exposure in HD patients are explained. Second, available regulatory and methodological guidelines for PK assessments in this population are summarized. Third, a 4-step approach is proposed to develop individual dose recommendations for HD patients receiving drugs without data from a PK study: (1) literature search, (2) model-based dosage decisions, (3) validation and refinement through concentration monitoring, and (4) publication of relevant observations. Fourth, clinician-initiated PK assessments and case reports to evaluate and individualize use of drugs in HD patients are reviewed, and recommendations to enhance their quality are discussed. Expert commentary: Guidance on collecting and reporting PK information in individual HD patients is warranted to ensure completeness and consistency of such PK studies. A checklist and template for easy-to-implement PK calculations and pharmacometric modeling is provided to facilitate evaluation and individualization of dosing strategies in these patients.

Pubmed
Web of science
Création de la notice
09/05/2017 18:54
Dernière modification de la notice
20/08/2019 14:24
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